An Ozempic lawsuit is a claim against the pharmaceutical company Novo Nordisk for causing acute gallbladder disease.
Ozempic (semaglutide) is a prescription injection medication used to regulate blood sugar and promote weight loss in type II diabetes mellitus patients. The pending lawsuits allege that:
- Ozempic is a dangerous drug that causes gallstones and inflammation, requiring gallbladder removal; and
- Novo Nordisk failed to adequately warn doctors and patients about these risks.
In this article, our Ozempic lawsuit attorneys discuss:
- 1. Does Ozempic cause acute gallbladder disease?
- 2. What are the symptoms of acute gallbladder disease?
- 3. What is the status of the litigation?
- 4. What money can I sue for?
- 5. What is Ozempic?
- 6. What should I do if I take Ozempic?
1. Does Ozempic cause acute gallbladder disease?
It appears likely that Ozempic causes acute gallbladder disease based on the following evidence:
- Clinical trials showed that a high percentage of patients developed gallstones (cholelithiasis) which doctors coded as a “serious event” necessitating gallbladder removal surgery (cholecystectomy).
- The drug’s own product label reports that none of the patients given a placebo reported gallstones; meanwhile, 1.5% of patients taking .5 mg of Ozempic reported gallstones, and .4% of patients taking 1 mg of Ozempic reported gallstones. And treatment was terminated with four patients experiencing four acute gallbladder events.
- The Federal Food and Drug Administration (FDA) Adverse Reporting System (FAERS) received many submissions from Ozempic users reporting gallbladder disorders coded as “serious adverse events.”
Furthermore, the Center for Drug Evaluation and Research (CDER) conducted a benefit-risk assessment in its clinical review of Ozempic: It acknowledges that its safety aligns with the “known safety profile” for GLP-1 Receptor Agonist Analog-Type drugs “with gastrointestinal adverse events being the most common adverse events.”1
2. What are symptoms of acute gallbladder disease?
Patients with acute gallbladder disease may experience gallstones (cholelithiasis) and gallbladder inflammation (cholecystitis). Symptoms include:
- jaundice (yellowing of the skin and eyes)
- bile duct stones
- sudden pain in the upper right or center of the abdomen or shoulders
- tenderness in the abdomen
The gallbladder‘s purpose is to hold bile (digestive fluid) that release into the small intestines. Gallstones (which are solid deposits of bile) can range in size. Some people develop only one, and others develop many.
Many people can peacefully co-exist with gallstones unless they migrate into a duct. This blockage can cause inflammation and possibly a life-threatening rupture – requiring gallbladder removal surgery (cholecystectomy).2
3. What is the status of the litigation?
The Ozempic litigation against Novo Nordisk is just starting, but tens of thousands of lawsuits are expected. The primary claims will be that Ozempic has a defective design and that Novo Nordisk failed to warn adequately doctors and patients about its risks.
The many Ozempic lawsuits will likely be consolidated into a federal multi-district litigation (MDL) in 2022 or 2023 in order to expedite the litigation and settlement process.
4. What money can I sue for?
Ozempic lawsuit plaintiffs are seeking damages for:
- Past and future medical expenses (including for gallbladder removal surgery);
- Past and future lost wages from being too ill to work;
- Past and future pain and suffering and loss of enjoyment of life; and
- Potential punitive damages.
Settlements are not expected for at least a couple of years.
5. What is Ozempic?
Ozempic – the brand name for the generic semaglutide – is a prescription medication that patients administer to themselves once a week through a prefilled pen-syringe. It can be injected in the
- upper arm,
- thigh, or
Doctors prescribe Ozempic to help control blood sugar levels (A1C) in type 2 diabetes mellitus patients.
The classification of Ozempic is a human Glucagon-like Peptide Receptor Agonist Analog-Type (GLP-1 RA). It is a non-insulin medication. But when it detects that blood sugar is too high, Ozempic causes the pancreas to secrete more insulin. It might also inhibit the liver from releasing too much sugar and slow digestion.
Ozempic was developed in 2012 by the Danish pharmaceutical company Novo Nordisk as a longer-acting option than the medication liraglutide. Clinical trials commenced in 2016. That same year, Novo Nordisk filed an FDA New Drug Application.
The following year, clinical trials of Ozempic finished, the FDA approved it as an injectable, and University of Leeds reported that it can help treat obesity. Then in 2018, Ozempic was approved for use in Canada, Japan, and the European Union.
(Novo Nordisk also makes a form of semaglutide that can be taken orally called Rybelsus. The FDA approved it in 2019, and it was approved in the EU the following year.)3
6. What should I do if I take Ozempic?
Contact your health care provider to discuss alternatives to Ozempic, and inquire about getting an abdominal ultrasound. If the scan shows gallbladder problems, contact our Ozempic lawsuit attorneys to discuss how we will fight for maximum financial compensation for your injuries.
- Andreea Ondina Lungu, Clinical Review: NDA 209637, Center for Drug Evaluation and Research (September 6, 2017).
, Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases, JAMA Intern Medi (March 28, 2022)(GLP1-RAs are associated with an increase in biliary or gallbladder diseases, particularly for patients who take higher doses for longer periods and for losing weight).
Cholelithiasis in patients treated with Glucagon-Like Peptide-1 Receptor: An updated meta-analysis of randomized controlled trials, Diabetes Res Clin Pract (March 16, 2020) (GLP1-RAs are associated with increased gallstone risks).
Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): Data from randomized controlled trials, Diabetes Obes Metab (September 19, 2019) (GLP1-RAs indicated increased risks of gallbladder inflammation).
Association of Bile Duct and Gallbladder Diseases With the Use of Incretin-Based Drugs in Patients With Type 2 Diabetes Mellitus, JAMA Intern Med (October 1, 2016)(853 of 71,369 patients on GLP-1 analogues were hospitalized for bile duct and gallbladder disease).
Kristen Monaco, GLP-1 Receptor Agonists: How Safe Are They for the Gallbladder? Medpage Today (March 28, 2022 ).
- Gallbladder Disease, Johns Hopkins Medicine.
Side Effects of Ozempic: What you need to know, Healthline.
- Anti-obesity drug acts on brain’s appetite control system, University of Leeds (October 24, 2017).
Ozempic (semaglutide) Injection, FDA.
Novo Nordisk A/S: Ozempic® (semaglutide) approved in the EU for the treatment of type 2 diabetes, GlobeNewsWire (February 9, 2018).
Diabetes drug Ozempic approved in Japan, ThePharmaLetter (March 23, 2018).
Ozempic® approved in Canada for the treatment of adults with type 2 diabetes, Newswire.ca (January 9, 2018).
FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014, FDA (June 1, 2021).